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510(k) Data Aggregation
K Number
K191083Device Name
COMPLETE CONTROL System Gen2
Manufacturer
Coapt, LLC
Date Cleared
2019-05-24
(30 days)
Product Code
GXY, CUT, IQZ
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Coapt, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.
Device Description
The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. The COMPLETE CONTROL System Gen2 simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.
The COMPLETE CONTROL System Gen2 is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on and does not require an additional battery.
The COMPLETE CONTROL System Gen2 is an embedded system that is used in conjunction with an upper-limb prosthetic device. The system has been validated for a specific set of prosthetic elbow, wrist and hand components which are listed in the user manual.
The COMPLETE CONTROL System Gen2 contains the following components:
- COMPLETE CONTROLLER main processor
- Device Interface Cable (clinician-specified termination type)
- EMG Interface Cable (clinician-specified termination type)
- COMPLETE CALIBRATE Button (part of COMPLETE CONTROLLER)
- Fabrication aid for the COMPLETE CONTROLLER
- Socket cut-out template for the COMPLETE CALIBRATE Button
- COMPELTE CONTROLROOM Application
- COMPLETE COMMUNICATOR Dongle
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K Number
K190416Device Name
Dome Electrode
Manufacturer
Coapt, LLC
Date Cleared
2019-04-04
(42 days)
Product Code
GXY, CUT
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Coapt, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).
Device Description
The Dome Electrode is an accessory designed for recording of biopotential signals. It is a non-invasive electrode that records biopotential signals from the surface of the skin. It has a standard mating thread that enables connection to electrical conductors of compatible devices. The Dome Electrode contains the following components: 316L Stainless Steel Dome Electrode, Stainless Steel Size 4-40 Nut, Stainless Steel Flat Washer, Stainless Steel Split ("Lock") Washer.
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K Number
K162891Device Name
Complete Control System
Manufacturer
COAPT, LLC
Date Cleared
2017-04-14
(179 days)
Product Code
GXY, HAN, IOZ, IQZ
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
COAPT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.
Device Description
The COMPLETE CONTROL System is an advanced control solution designed to enhance the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System employs Pattern Recognition technology to acquire, non-invasively, the rich information in muscle signals to enhance the control of industry standard upper extremity prostheses. Patients can achieve intuitive control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. COMPLETE CONTROL simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.
The COMPLETE CONTROL System is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on. COMPLETE CONTROL does not require an additional battery.
The COMPLETE CONTROL System is an embedded system that is used in conjunction with an upper-limb prosthetic device. This device can include any combination of an elbow, wrist, hand or terminal device. It contains several modules, including one for processing surface EMG (CO-AMP), processing and translating the signals (CONTROLLER), along with a controlling training routine (CALIBRATE). Finally, a wireless adapter (COMMUNICATOR) is included with the system setup and is used to provision the entire system.
The COMPLETE CONTROL System contains the following components.
- 1. Device Interface Cable (clinician-specified termination type)
- 2. COMPLETE CONTROLLER main processor
- 3. COMPLETE CALIBRATE patient interface button
- 4. COMPLETE CO-AMP consolidated EMG amplifier
- 5. EMG Interface Cable
- 6. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
- 7. Socket cut-out template for the COMPLETE CALIBRATE button
- 8. COMPLETE COMMUNICATOR USB dongle
- 9. COMPLETE CONTROLROOM software installation USB dongle
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